Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | LCS TOTAL KNEE SYSTEM |
Generic Name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P830055 |
Supplement Number | S087 |
Date Received | 09/16/2003 |
Decision Date | 11/18/2003 |
Product Code |
NJL |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LINE EXTENSION TO THE P.F.C. SIGMA COMPONENTS. THAT IS, THE ADDITION OF P.F.C. SIGMA RPF FEMORAL COMPONENTS AND TIBIAL BEARINGS (SIZES 1, 1.5, 2, 2.5, 3, 4, 5, AND 6). THE P.F.C. SIGMA RPF COMPONENTS ALLOW FOR A HIGHER THAN NORMAL DEGREE OF FLEXION AFTER TOTAL KNEE ARTHROPLASTY (~155 DEGREES). |
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